The following data is part of a premarket notification filed by American Optical Corp. with the FDA for Photolite Aolite Tintomatic Lens.
| Device ID | K812051 |
| 510k Number | K812051 |
| Device Name: | PHOTOLITE AOLITE TINTOMATIC LENS |
| Classification | Lens, Spectacle, Non-custom (prescription) |
| Applicant | AMERICAN OPTICAL CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HQG |
| CFR Regulation Number | 886.5844 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-07-21 |
| Decision Date | 1981-09-08 |